K871495 is an FDA 510(k) clearance for the BANDAGES CATALOG NUMBER: 101 TO 220. This device is classified as a Dressing, Wound, Occlusive (Class I - General Controls, product code NAD).
Submitted by I M, Inc. (Fairfield, US). The FDA issued a Cleared decision on May 8, 1987, 22 days after receiving the submission on April 16, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4020.
| 510(k) Number | K871495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 1987 |
| Decision Date | May 08, 1987 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | NAD — Dressing, Wound, Occlusive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4020 |